ALISO VIEJO, Calif.--(BUSINESS WIRE)--Valeant Pharmaceuticals International (NYSE:VRX) today announced that it has acquired the commercial rights to nabilone in the United Kingdom and other European markets from Cambridge Laboratories for $14 million. Valeant markets nabilone in the United States and Canada under the brand name Cesamet®. Nabilone is indicated for use in the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetic treatments.
“There remains a need for cannabinoids like Cesamet for patients who have exhausted conventional treatments and whose quality of life continues to be adversely impacted by the debilitating side effects of cancer chemotherapy,” said Timothy C. Tyson, Valeant’s president and chief executive officer. “Our customer relationships and our experience with the product will position us to meet this need. The purchase also allows us to expand one of our key products into these important markets.”
Valeant acquired Cesamet from Eli Lilly & Company in 2000 and currently sells the product both in Canada, where it has an 87 percent share of the cannabinoid market, and in the United States. Nabilone is the only licensed cannabinoid in the United Kingdom. It has more than 25 years of clinical experience in the United Kingdom and Canada.
Important Safety Information
Nabilone, a synthetic cannabinoid similar to the active ingredient found in naturally occurring Cannabis sativa L (marijuana; delta-9-THC), is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid, and in the treatment of nausea arising from any cause other than chemotherapy. Patients receiving treatment with nabilone should be advised that nabilone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as operating machinery or driving a car. During controlled clinical trials of nabilone, virtually all patients experienced at least one adverse reaction. The most commonly encountered events were drowsiness, vertigo or dizziness, dry mouth, euphoria (feeling “high”), ataxia, headache, concentration difficulties, sleep disturbances, dysphoria, hypotension, nausea and visual disturbances. Nabilone should be administered with caution to patients taking any CNS depressants, including alcohol, sedatives, hypnotics, or other psychoactive substances because these substances can potentiate the central nervous system effects of nabilone. Since nabilone can elevate supine and standing heart rates and cause postural hypotension, it should be used with caution in the elderly, and in patients with hypertension or heart disease. Nabilone should also be used with caution in patients with current or previous psychiatric disorders (including manic depressive illness, depression and schizophrenia), as the symptoms of these disease states may be unmasked by the use of cannabinoids.
The capability of nabilone to cause dependence is not known. Nabilone should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence and marijuana use, since nabilone is similar to the active ingredient found in naturally occurring marijuana. Nabilone should be used with caution in pregnant patients, nursing mothers, or pediatric patients because it has not been studied in these patient populations.
Valeant Pharmaceuticals International (NYSE:VRX) is a global specialty pharmaceutical company that develops, manufactures and markets products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.
Cesamet is a registered trademark of Valeant Pharmaceuticals International or its related companies. All other trademarks are the trademarks or the registered trademarks of their respective owners.
This press release contains forward-looking statements, including, but not limited to, statements regarding the potential expansion of the company’s Cesamet business in the United Kingdom and other European markets. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties relating to the company’s ability to expand its Cesamet business, and other risks and uncertainties discussed in the company’s filings with the U.S. Securities and Exchange Commission. Valeant wishes to caution the reader that these factors are among the factors that could cause actual results to differ materially from the expectations described in the forward-looking statements. Valeant also cautions the reader that undue reliance should not be placed on any of the forward-looking statements, which speak only as of the date of this release. The company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this release or to reflect actual outcomes.